Is Ibritumomab tiuxetan approved by the US FDA?

Drugs@FDA lists 1 application product line for Ibritumomab tiuxetan, including ZEVALIN (Prescription).

Is Ibritumomab tiuxetan authorised in the European Union?

EMA lists 0 centrally authorised medicines containing Ibritumomab tiuxetan.

Are there safety signals or safety updates for Ibritumomab tiuxetan?

US FDA: 1 entry (latest 2018-12-11).

Active substance

Ibritumomab tiuxetan

US FDA 1
EMA 1
Safety 1

Open in the medicines table

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ZEVALIN	3.2MG/2ML	injectable · injection	SPECTRUM PHARMS	Prescription	19 Feb 2002

EMA European Union — centrally authorised medicines

Zevalin Ceft Biopharma s.r.o. · Lapsed · authorised 16 Jan 2004 · ATC V10XX02

Therapeutic indication (EMA)

Zevalin is indicated in adults. [90Y]-radiolabelled Zevalin is indicated as consolidation therapy after remission induction in previously untreated patients with follicular lymphoma. The benefit of Zevalin following rituximab in combination with chemotherapy has not been established. [90Y]-radiolabelled Zevalin is indicated for the treatment of adult patients with rituximab relapsedorrefractory CD20+ follicular B-cell non-Hodgkin's lymphoma (NHL).

Safety signals and safety-related labeling changes

US FDA 11 Dec 2018 ZEVALIN — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide

All safety entries for ibritumomab tiuxetan →

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.